Human Mass Balance Study of AJM300: A Clinical Pharmacology Study to Investigate the Absorption, Metabolism, and Excretion of 14C-AJM300 after a Single Oral Dose in Healthy Adult Male Subjects

Phase 1

Completed

• Conditions: Healthy adult subjects

• Registration Number: JPRN-jRCT2080224740
• Lead Sponsor: EA Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-21
• Study Completion: 2020-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

A BMI of >=18.5 to <25.0 kg/m2
- Deemed by the investigator or subinvestigator to have no clinically relevant abnormalities based on medical examination findings, vital signs, electrocardiogram, and laboratory tests and having no problems participating in this clinical study
- Able to consent in writing to participate in this clinical study based on their own free will and to comply with the requirements of this study

Exclusion Criteria

Main exclusion criteria

- Intake of a supplement containing garlic as the main ingredient within 6 weeks before administration of the investigational product
- Intake of grapefruit, grapefruit juice, or food containing grapefruit components within 8 days before administration of 14C-AJM300
- Intake of St. John's wort or food containing its ingredients within 15 days before administration of 14C-AJM300
- A white blood cell count of 3000/micro-L or less in the laboratory tests at screening or on the day of admission or the day of dosing in Part 2
- A medical history, within 1 year before administration of 14C-AJM300, of or an ongoing serious infection
- Any central nervous system symptoms
- Receiving any dose of radioisotope-labeled substance or exposure to a large amount of radioactivity within 1 year before administration of 14C-AJM300
- Occupational exposure to radiation within 1 year before administration of 14C-AJM300

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacokinetics<br>- Total 14C radioactivity: Whole blood and plasma radioactivity concentrations, and urinary and fecal excretion rates of radioactivity<br>- Plasma drug concentrations: AJM300 and AJM300 metabolites<br>- Urinary drug concentrations (excretion rates): AJM300 and AJM300 metabolites<br>- Pharmacokinetic parameters<br>- Plasma, urinary, and fecal metabolite profiles

Secondary Outcome Measures

Name	Time	Method
safety<br>- Physical examination<br>- Vital signs<br>- Electrocardiogram (ECG) (standard 12-lead ECG)<br>- Laboratory tests<br>- Adverse events